BASIC LAP PACK
Report
- Report Number
- 3005011024-2024-00007
- Event Type
- Malfunction
- Date Received
- March 21, 2024
- Date of Event
- October 31, 2023
- Report Date
- March 21, 2024
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- FDE
- UDI-DI
- 00749756363105
- PMA / PMN Number
- ENFDISC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A USER FACILITY MEDWATCH REPORT (#4913020000-2023-8004) WAS RECEIVED ON 02/26/2024 REPORTING HOLE IN PACK PRIOR TO OPENING, SUCTION PUNCTURED THROUGH OUTER PACKAGING. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED. ROOT CAUSE: POSSIBLY ROUGH HANDLING, DURING CASING, OR SHIPPING FROM AN UNKNOWN SOURCE. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN TAKEN BY DEROYAL: THIS ISSUE HAS BEEN REVIEWED WITH THE ROOM SUPERVISORS DUE TO NO LOT NUMBER BEING PROVIDED. ADDITIONAL GUIDANCE WAS GIVEN TO MANUFACTURING TO INDICATE THAT THIS PRODUCT HAS HAD A REPORT OF HOLE IN BACK TABLE COVER TO INCREASE SCRUTINY DURING THE ASSEMBLY AND CASING PROCESS. AN INVENTORY CHECK OF THE TRAY WAS MADE BY DEROYAL, A TOTAL OF 8 TRAYS OF THE 89-10501 LOT 60124321 WERE INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
HOLE IN PACK PRIOR TO OPENING, SUCTION PUNCTURED THROUGH OUTER PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524544 | BASIC LAP PACK | LAPAROSCOPY KIT | FDE | DEROYAL INDUSTRIES, INC. | 89-10501 | 00749756363105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |